Biobot Surgical Pte., Ltd. FDA Approvals

0 new drug approvals and 3 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
iSR`obot Mona Lisa 2.0510(k)Dec 21, 2023Radiology	Radiology	510(k)Substantially Equivalent (Special)	Dec 21, 2023
iSRobot Mona Lisa 2.0510(k)Dec 22, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 22, 2021
iSR'obot Mona Lisa 1.0510(k)Jul 8, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 8, 2021